FDA Delays Intended Use Language Indefinitely, Citing Need For Clarification

FDA announced on Friday (Jan. 12) that it will continue to delay until further notice a controversial regulatory measure that would factor “the totality of the evidence” into agency decisions regarding a drug or device manufacturer's intended use of a product and communications about such uses. The language will also be removed from the tobacco rule in which it was originally included as the agency moves to implement the rest of the rule's tobacco-related provisions. The rule, “Clarification of When...